New Phase 3 Data Showed PRISTIQ Significantly Reduced Symptoms of Major Depressive Disorder Vers...(of the two studies to theU.S. Food and D...)

Date:12/12/2007

of the two studies to the U.S. Food and Drug Administration (FDA) as part of its complete response to the FDA approvable letter it received in January 2007 for PRISTIQ for the treatment of MDD. FDA action on the application is expected during the first quarter of 2008. The clinical data for PRISTIQ presented at the meeting represent only a portion of the data from the ongoing clinical development of PRISTIQ and are not necessarily representative of the totality of data and other information that may affect further development, regulatory review and/or commercialization of PRISTIQ.

More About the Studies

Poster 145: Liebowitz M., et al. Evaluation of the Efficacy and Safety of Fixed Doses of Desvenlafaxine Succinate at 50 mg and 100 mg in Outpatients with Major Depressive Disorder in 2 Placebo-Controlled Trials

Data presented are from two identically designed multicenter, randomized, double-blind, placebo-controlled, eight-week studies, one conducted outside of the United States involving 483 adult patients, and one in the U.S. with 447 adult patients. Primary efficacy in both trials was determined based on change from baseline score on the 17-item Hamilton Depression Rating Scale (HAM-D17). Patients in both desvenlafaxine groups started treatment at 50 mg/day. For the 100 mg/day group, the dose was increased to 100 mg/day on the eighth day of the study.

Efficacy Analysis

The results of both trials showed that at the 50 mg/day dose, desvenlafaxine was associated with a significant reduction in the symptoms of MDD as measured by HAM-D17 scores over eight weeks compared with placebo (ex-US: p=0.002, 50 mg = -13.2, placebo = -10.7; U.S.: p=0.018, 50 mg = -11.5, placebo = -9.5). While the 100 mg/day dose showed a statistically significant improvement in the international study versus placebo (p<0.001, 100 mg = -13.7), this dose did not statistically separate from placebo in the U.S. study (p=0.065, 100 mg = -11.0).

Safety Analys
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